---
kind: "section"
citation: "21 C.F.R. § 209.1"
title: "21"
number: "209.1"
heading: "Scope and purpose."
url: "https://uscodex.org/cfr/21/209.1"
---

# §209.1. Scope and purpose.

- (a) This part sets forth requirements for human prescription drug products approved under [section 505](/cfr/21/505.md) of the Federal Food, Drug, and Cosmetic Act and dispensed by authorized dispensers and pharmacies to consumers. This part requires distribution of a side effects statement and applies to new and refill prescriptions. This part is not intended to apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital or health care facility under an order of a licensed practitioner, or as part of supervised home health care.
- (b) The purpose of providing the side effects statement is to enable consumers to report side effects of prescription drug products to FDA.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241.

### Source

Source: 73 FR 404, Jan. 3, 2008, unless otherwise noted.